Coronary Artery Lesions With Implantation of Coronary DeviceREPARANCT02256449
REPARA Study: REgistry of PAtients With bioResorbable Device in Daily Clinical prActice
An observational study of Coronary Artery Lesions With Implantation of Coronary Device, run by Sección Hemodinamica y Cardiologia Intervencionista at 1 site in Spain.
Trial summary
A multicentre, observational, prospective device registry, with no control group, designed to evaluate the efficacy and safety of the bioresorbable coronary device, used according to the indications of use, in daily clinical practice in a consecutive number of patients undergoing PCI in de novo coronary artery… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Lesions With Implantation of Coronary Device
- How many people
- 2,440 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2014to Oct 2016
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with native coronary artery de novo lesions with indication for revascularization with a coronary device
Who may be able to join
- Patient must be at least 18 years of age at the time of signing the Informed Consent Form
- Patient is to be treated for de novo coronary lesions in a native coronary artery and amenable to receive a bioresorbable device
- The length of the treated lesion should be inferior to the nominal length of the device (12 mm, 18 mm, 28 mm) with a reference vessel diameter > 2 mm y < 3,8 mm.
- The patient will not have any relative contraindication for double antiplatelet therapy, with aspirin indefinitely and with a thienopyridine for at least 6 months
Who cannot join
- Cardiogenic shock
- Left main disease
- Aortocoronary graft
- Intrastent restenosis
- Potentially child-bearing women with no contraceptive methods
- Pregnant or breast-feeding women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Registry of Patients With Bioresorbable Device in Daily Clinical Practice. REPARA Study
A multicentre, observational, prospective device registry, with no control group, designed to evaluate the efficacy and safety of the bioresorbable coronary device, used according to the indications of use, in daily clinical practice in a consecutive number of patients undergoing PCI in de novo coronary artery lesions. A total of 1,500 patients are planned to be included in the registry.
Read the detailed description
The patients will be included consecutively at each site for one year. They will be individuals from both sexes, requiring endovascular intervention and meeting the authorised criteria for the indications of use of the device to be used and where dual anti-platelet therapy (DAPT) with aspirin and thienopyridines is considered.
STUDY OBJECTIVES To evaluate the MACE rate after implantation of the bioresorbable coronary device in patients with de novo coronary artery lesions, where a follow-up of 12 months will be performed.
Primary objective:
MACE rate at 12 months of follow-up:
Cardiac death Myocardial infarction TLR driven by ischaemia of the lesion treated or of the region of 5 mm proximally or distally to the site of implantation of the device (ID-TLR).
Secondary objectives:
- Angina
- Death due to any cause.
- Myocardial infarction of any type (MI: QMI, NQMI, TV, NTV)
- All TLR driven or not by ischaemia
- All TVR driven or not by ischaemia.
- All coronary revascularisations performed (PCI vs CABG)
- Device thrombosis (acute, sub-acute, late) and evidence (definitive, probable, possible).
- Immediate success of the device.
- Immediate success of the procedure.
- Rate of patients with DAPT at < 1 month, 1-3 months, 3-6 months, and 6-12 months and relationship with the occurrence of events
- Composite endpoints:
Cardiac death, TV-MI and ID-TLR: (Target Lesion Failure (TLF)) Cardiac death, any myocardial infarction (MI) and ID-TVR: (Target Vessel Failure (TVF))
- Rate of overlapping devices: characteristics and relationship with occurrence of events
- Collection of imaging data of the cases where, according to the judgement of the investigator, intravascular imaging tests have been performed (IVUS, OCT).
- Keywords
- Coronary artery disease; angioplasty; bioresorbable device
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| BVS patients | Use of bioresorbable coronary device, according to the indications of use, in daily clinical practice, in patients undergoing PCI in de novo coronary artery lesions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
MACE rate (major adverse cardiac events) at 12 months of follow-up: Cardiac death; Myocardial infarction; Target lesion revascularisation (TLR) ischemia-driven: Cardiac Death/All MI/ID-TLR
Measured: Clinical follow-up at 12 months
Secondary outcomes (8)
Immediate success of the device/procedure
Measured: 1 day
Cardiac death
Measured: 12 months
Myocardial infarction
Measured: 12 months
Scaffold/Stent Thrombosis: Timing and Evidence
Measured: 12 months
Target lesion/vessel revascularization (TLR/TVR)
Measured: 12 months
Angina Events
Measured: 12 months
Rate of patients with DAPT at 12 months
Measured: 12 months
Rate of overlapping devices and characteristics
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2014 (estimated)
- Study startJan 2014
- Primary completionSep 2015
- Study completionOct 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Lesions With Implantation of Coronary DeviceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,440 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Sección Hemodinamica y Cardiologia Intervencionista
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Felipe Hernandez, MD, Principal investigator, Seccion Hemodinamica y Cardiologia Intervencionista
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02256449
- Sponsor's protocol ID
- COR-BVS-2013-01
- Acronym
- REPARA
- Status last verified
- Jul 2016
- First submitted
- 23 Sep 2014
- Last updated
- 18 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry of Patients With Bioresorbable Device in Daily Clinical Practice. REPARA Study
- ClinicalTrials.gov ID
- NCT02256449
- Acronym / sponsor ID
- REPARA / COR-BVS-2013-01
- Keywords
- Coronary artery disease; angioplasty; bioresorbable device
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,440 participants (actual)
- Lead sponsor
- Sección Hemodinamica y Cardiologia IntervencionistaUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Oct 2016 (estimated)
- First posted
- 3 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A multicentre, observational, prospective device registry, with no control group, designed to evaluate the efficacy and safety of the bioresorbable coronary device, used according to the indications of use, in daily clinical practice in a consecutive number of patients undergoing PCI in de novo coronary artery lesions. A total of 1,500 patients are planned to be included in the registry.
Detailed description
The patients will be included consecutively at each site for one year. They will be individuals from both sexes, requiring endovascular intervention and meeting the authorised criteria for the indications of use of the device to be used and where dual anti-platelet therapy (DAPT) with aspirin and thienopyridines is considered.
STUDY OBJECTIVES To evaluate the MACE rate after implantation of the bioresorbable coronary device in patients with de novo coronary artery lesions, where a follow-up of 12 months will be performed.
Primary objective:
MACE rate at 12 months of follow-up:
Cardiac death Myocardial infarction TLR driven by ischaemia of the lesion treated or of the region of 5 mm proximally or distally to the site of implantation of the device (ID-TLR).
Secondary objectives:
- Angina
- Death due to any cause.
- Myocardial infarction of any type (MI: QMI, NQMI, TV, NTV)
- All TLR driven or not by ischaemia
- All TVR driven or not by ischaemia.
- All coronary revascularisations performed (PCI vs CABG)
- Device thrombosis (acute, sub-acute, late) and evidence (definitive, probable, possible).
- Immediate success of the device.
- Immediate success of the procedure.
- Rate of patients with DAPT at < 1 month, 1-3 months, 3-6 months, and 6-12 months and relationship with the occurrence of events
- Composite endpoints:
Cardiac death, TV-MI and ID-TLR: (Target Lesion Failure (TLF)) Cardiac death, any myocardial infarction (MI) and ID-TVR: (Target Vessel Failure (TVF))
- Rate of overlapping devices: characteristics and relationship with occurrence of events
- Collection of imaging data of the cases where, according to the judgement of the investigator, intravascular imaging tests have been performed (IVUS, OCT).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BVS patients | – | –Use of bioresorbable coronary device, according to the indications of use, in daily clinical practice, in patients undergoing PCI in de novo coronary artery lesions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with native coronary artery de novo lesions with indication for revascularization with a coronary device
Key inclusion criteria (4 listed)
- Patient must be at least 18 years of age at the time of signing the Informed Consent Form
- Patient is to be treated for de novo coronary lesions in a native coronary artery and amenable to receive a bioresorbable device
- The length of the treated lesion should be inferior to the nominal length of the device (12 mm, 18 mm, 28 mm) with a reference vessel diameter > 2 mm y < 3,8 mm.
- The patient will not have any relative contraindication for double antiplatelet therapy, with aspirin indefinitely and with a thienopyridine for at least 6 months
Key exclusion criteria (6 listed)
- Cardiogenic shock
- Left main disease
- Aortocoronary graft
- Intrastent restenosis
- Potentially child-bearing women with no contraceptive methods
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
MACE rate (major adverse cardiac events) at 12 months of follow-up: Cardiac death; Myocardial infarction; Target lesion revascularisation (TLR) ischemia-driven: Cardiac Death/All MI/ID-TLR
Time frame: Clinical follow-up at 12 months
8 secondary outcomes
Immediate success of the device/procedure
Time frame: 1 day
Cardiac death
Time frame: 12 months
Myocardial infarction
Time frame: 12 months
Scaffold/Stent Thrombosis: Timing and Evidence
Time frame: 12 months
Target lesion/vessel revascularization (TLR/TVR)
Time frame: 12 months
Angina Events
Time frame: 12 months
Rate of patients with DAPT at 12 months
Time frame: 12 months
Rate of overlapping devices and characteristics
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Felipe Hernandez, MD principal investigator
Seccion Hemodinamica y Cardiologia Intervencionista
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Lesions With Implantation of Coronary Device, run by Sección Hemodinamica y Cardiologia Intervencionista at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MACE rate (major adverse cardiac events) at 12 months of follow-up: Cardiac death; Myocardial infarction; Target lesion revascularisation (TLR) ischemia-driven: Cardiac Death/All MI/ID-TLR (time frame: Clinical follow-up at 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2016.